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| Sponsor: | Drexel University College of Medicine |
|---|---|
| Collaborator: |
Coulter Foundation |
| Information provided by: | Drexel University |
| ClinicalTrials.gov Identifier: | NCT00578604 |
Purpose
The objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. Our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. Our hope is that the fNIR optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.
| Condition |
|---|
|
Diabetic Foot Ulcers |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Non-Invasive Assessment of Wound Healing With Optical Methods |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 1 |
| 2 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Recruited patients will be patients with diabetes who have chronic wounds and will likely have other co-morbidities associated with chronic diabetes.
Control subjects do not have diabetes and do not have wounds.
Healthy Subject inclusion criteria
Patient Subject inclusion criteria:
EXCLUSION CRITERIA
Contacts and Locations| United States, Pennsylvania | |
| Drexel University College of Medicine Wound Care Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Michael S Weingarten, M.D. 215-762-7008 msw34@drexel.edu | |
| Principal Investigator: | Michael S Weingarten, M.D. | Drexel University College of Medicine |
More Information
| Responsible Party: | Drexel University College of Medicine ( Michael S. Weingarten, M.D. ) |
| Study ID Numbers: | 17035 |
| Study First Received: | December 20, 2007 |
| Last Updated: | April 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00578604 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Foot Ulcer Skin Diseases Diabetic Neuropathies Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Cardiovascular Diseases Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |